Unlocking the Potential of Cell and Gene Therapies
From tight timelines to regulatory hurdles to ensuring dosing and quality standards, bringing a therapy to market comes with challenges.
Navigating the path from early development to commercialization of a cell or gene-modified cell therapy takes technical, regulatory, scientific, and manufacturing know-how. Without this expertise, drug developers face inefficiencies that can increase costs and cause delays as well as quality risks. By partnering with a CDMO with a proven track record, we can guide you to flexible, scalable manufacturing solutions that streamline development, reduce risk, and accelerate progress.
Accelerating Speed to Clinic with the Cell Therapy Flex Platform
When you’re working to transform possibilities into breakthroughs, time is of the essence. In this case study you’ll learn how one autologous CAR-T client went from first process run to IND approval in just 8 months by streamlining the CGT workflow for process development, testing, tech transfer and GMP prep.
Download NowUnderstanding the Path to Manufacturing Immunotherapies
As the field evolves for autologous and allogeneic cell therapies, so does the applications for curing cancers, autoimmune diseases, and other conditions. But with that promise, comes increasing pressure to get development right. In this guide, explore strategies for navigating analytical and process development as well as GMP readiness.
Explore NowScaling CAR-T Manufacturing with Large-Volume Fill-Finish
As the number of cell and gene therapies in development grows, so too does the need to effectively and efficiently scale drug product formulation and fill-finish to meet market demand. After putting one automated and closed fill-finish system to the test, check out the results in this whitepaper.
Discover HowAchieving CGT Development Success with the Program Roadmap
Maintaining drug development timelines is critical to reaching funding milestones, especially as a therapy moves through late-stage clinical trials to commercialization. To accelerate production and help developers seamlessly move from clinical to commercial manufacturing, our CDMO experts leverage the CGT Program Roadmap with validated workflows and protocols.
Read MoreHow to Use AI and Machine Learning in Cell Therapy Process Development
AI and machine learning are buzzwords across many industries. But how can they assist cell therapy manufacturing and what is the right approach to apply such emerging technologies? Watch this webinar on-demand and learn about a case study where we used AI to optimize perfusion in allogeneic T cell manufacturing.
Learn MoreExpert Insights to Navigate Critical CGT Challenges
At Charles River’s Cell & Gene Therapy Summit in San Francisco this year, industry leaders and experts came together for a day of sharing insights to help developers navigate the complexities of CGT. Hear from the leading minds with interviews on market insights, industry trends, and development tips.
Watch NowEnhancing Non-viral Engineering of Cells for Cell Therapy Manufacturing
With the growth of gene-modified cell therapies, advanced technologies are needed to improve the methods for both viral and non-viral transfection of cells. Learn more about our insights after we assessed leading, commercially available electroporation platforms that are widely used to engineer T cells primarily for immunotherapies.
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